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The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD)

Primary Purpose

Crohn's Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

azathioprine+enteral nutrition

Azathioprine

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, maintain remission, postoperative recurrence, surgery, living quality

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease
Lesions located in ileum or ileocecal region
Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
Body weight between 40 and 100 kg, inclusive.
Subjects should have a CDAI score <150 at week 0
Able to swallow tablets
Are capable of providing written informed consent and obtained at the time of enrollment
Willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

Bacterial,viral or other microbial infection(including HIV)
any of the following medications taken within 12 weeks before surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or other investigational drugs
any of ongoing therapy for Crohn's disease with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, and tube feeding
Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
Previous or current use of infliximab.
current use of prescription doses or chronic/frequent use of NSAIDs
Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted, providing that the dose is not increased during the study period.)
History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
WBC <3.0 x 109/L, hemoglobin <80 g/L, Platelets<50,000/mm3 at the time of enrollment (or within the previous 6 months, if known)
History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known)
With short bowel syndrome (defined as requiring oral or parenteral supplemental or total nutrition to maintain stable body weight, or more than 100 cm of small bowel resected)
History of malignancy
Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
Participation in other clinical trial within the past 6 months

Sites / Locations

General Surgery Institute,Jinling HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

enteral nutrition+azathioprine

azathioprine

Arm Description

Patients is fasting and receive enteral nutrition and azathioprine treatment.

Patients have regular diet and receive only azathioprine treatment.

Outcomes

Primary Outcome Measures

The change of patients'CDAI.

patients' endoscopic score(Rutgeerts score).

Secondary Outcome Measures

The change of haematological inflammation marker(CRP,ESR)

The change of patients'IBDQ.

The change of blood routine examination and blood biochemistry.

Full Information

NCT ID

NCT01823042

First Posted

March 25, 2013

Last Updated

March 28, 2013

Sponsor

Jinling Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT01823042

Brief Title

The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD)

Official Title

A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD).

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

July 2013 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinling Hospital, China

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken medicine.There is a treatment blank period between surgery and onset time of maintain remission medications.Enteral nutrition has been used in the induction remission and maintain remission for CD.May be it can fill the treatment blank period.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn's Disease, maintain remission, postoperative recurrence, surgery, living quality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

enteral nutrition+azathioprine

Arm Type

Experimental

Arm Description

Patients is fasting and receive enteral nutrition and azathioprine treatment.

Arm Title

azathioprine

Arm Type

Experimental

Arm Description

Patients have regular diet and receive only azathioprine treatment.

Intervention Type

Drug

Intervention Name(s)

azathioprine+enteral nutrition

Intervention Type

Drug

Intervention Name(s)

Azathioprine

Primary Outcome Measure Information:

Title

The change of patients'CDAI.

Time Frame

at 0 week, the 4 weeks, the 8 weeks, the 12weeks

Title

patients' endoscopic score(Rutgeerts score).

Time Frame

at the 12weeks

Secondary Outcome Measure Information:

Title

The change of haematological inflammation marker(CRP,ESR)

Time Frame

at 0 week, the 4 weeks, the 8 weeks, the 12weeks

Title

The change of patients'IBDQ.

Time Frame

at 2 week, the 6 weeks, the 12 weeks

Title

The change of blood routine examination and blood biochemistry.

Time Frame

at 0 week,4 weeks,8 weeks,12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease Lesions located in ileum or ileocecal region Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment. Body weight between 40 and 100 kg, inclusive. Subjects should have a CDAI score <150 at week 0 Able to swallow tablets Are capable of providing written informed consent and obtained at the time of enrollment Willing to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: Bacterial,viral or other microbial infection(including HIV) any of the following medications taken within 12 weeks before surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or other investigational drugs any of ongoing therapy for Crohn's disease with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, and tube feeding Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable. Previous or current use of infliximab. current use of prescription doses or chronic/frequent use of NSAIDs Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted, providing that the dose is not increased during the study period.) History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis) WBC <3.0 x 109/L, hemoglobin <80 g/L, Platelets<50,000/mm3 at the time of enrollment (or within the previous 6 months, if known) History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known) With short bowel syndrome (defined as requiring oral or parenteral supplemental or total nutrition to maintain stable body weight, or more than 100 cm of small bowel resected) History of malignancy Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period. Participation in other clinical trial within the past 6 months

Facility Information:

Facility Name

General Surgery Institute,Jinling Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

wei ming zhu, PhD,MD

Phone

+86-25-80860137

dr_zhuweiming@126.com

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD)

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